Acumen IQ AIQS8R

GUDID 00690103201161

Acumen IQ Sensor

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use

• Primary Device ID: 00690103201161
• NIH Device Record Key: 0676ec8a-f510-4c68-b678-bd954055580e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acumen IQ
• Version Model Number: AIQS8R
• Catalog Number: AIQS8R
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Length: 84 Inch
• Length: 84 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103201161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152980

FDA Product Code

• DRS: Transducer, Blood-Pressure, Extravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-04
• Device Publish Date: 2019-01-04

On-Brand Devices [Acumen IQ ]

• 50690103201173: Acumen IQ Sensor
• 00690103201161: Acumen IQ Sensor
• 00690103201086: Acumen IQ Sensor
• 50690103200947: Acumen IQ Sensor
• 50690103201005: ACUMEN IQ SENSOR 60" / 152CM Double Line Kit -- With VAMP
• 00690103201093: ACUMEN IQ SENSOR 60" / 152CM with Red Cap
• 50690103200954: ACUMEN IQ SENSOR 60" / 152CM with Red Cap
• 50690103200930: ACUMEN IQ SENSOR 60" / 152CM 5-Pack
• 00690103201079: ACUMEN IQ SENSOR 60" / 152CM